In a recent class action decision, Wise v. Abbott Laboratories Limited (Wise), Justice Perell of the Ontario Superior Court of Justice (Court) granted the defendant’s motion for summary judgment in advance of certification, concluding that there was no genuine issue requiring a trial because there was insufficient evidence of general causation. The decision highlights the potential for defendants to use of summary judgment to resolve a class action before certification in appropriate cases.
Abbott Laboratories (Abbott) is the manufacturer of a topical ointment known as AndroGel®, a testosterone replacement therapy for the treatment of hypogonadism (testosterone deficiency) in men.
The representative plaintiff brought a proposed class action against Abbott alleging that AndroGel causes serious cardiovascular (CV) events, such as heart attacks and strokes; and that AndroGel was sold by Abbott as a remedy for “LowT”, an alleged fabricated disease made up by Abbott to sell more of its product. In selling AndroGel for LowT, the plaintiffs alleged that the drug had no therapeutic benefits, and that Abbott had therefore been unjustly enriched and should compensate the class members for their economic losses incurred in purchasing the product. The plaintiffs also sought recovery of damages from the defendant based on the allegations of failure to warn and the novel claim of “waiver of tort”.
Abbott denied all claims of negligence, and submitted that the plaintiffs’ claims should be dismissed on the grounds that they could not prove general causation, which was a constituent element in all of their product liability claims. Conversely, the plaintiffs submitted that if they won, the case would be appropriate for a partial summary judgment in their favour — with the result that three of the five certification criteria would be satisfied.
Significantly, the parties filed more than 11,000 pages in materials for the motion, including 22 expert reports from nine experts. There were six days of oral argument.
The Court held that there were four major issues on the motion. The Court’s findings with respect to each of these issues are briefly canvassed below.
Is the Case Appropriate for Summary Judgment?
The Court held that at the heart of the “no genuine issue requiring a trial” test for granting summary judgment is the need to undertake a “judicial gut check.” The motions judge must be of the view that sufficient evidence has been presented on all relevant points to allow him or her to draw the inferences necessary to make dispositive findings. Justice Perell concluded that the case at bar was an appropriate case for summary judgment because he had “no doubt” that he had sufficient evidence on all relevant points and both sides had put forward sufficient evidence to make their respective arguments about the dispositive issues.
Is There a Genuine Issue Requiring a Trial About General Causation?
On this issue, the Court held that a constituent element of the tort of negligence is that the defendant’s negligence caused the plaintiff’s injuries. The Court went on to discuss two aspects to the proof of causation: “general causation”, which concerns whether the defendant’s misconduct has the capacity to cause the alleged harm; and “specific causation”, which concerns whether the general capacity to harm was actualized in the particular case.
The defendant’s relied heavily on the landmark decision Andersen v. St. Jude Medical Inc. (St. Jude) to argue that in order to meet the legal standard of proof based on a balance of probabilities, a minimum statistical risk ratio of 2.0 must be demonstrated in order to establish general causation. The Court, however, disagreed. First, the Court distinguished St. Jude by holding that the 2.0 risk ratio in St. Jude arose in the context of the court’s discussion of specific causation, which Justice Perell held “has little to do with the risk ratio threshold for proof of general causation”. Second, he was not prepared to find that legal proof of general causation should be confined to statistical analysis alone.
While the Court was prepared to find on the evidence that there was a genuine issue about general causation — in particular, whether AndroGel could cause serious CV events — using its fact-finding powers under the summary judgment rules, the Court found that the plaintiffs had failed to establish general causation on a balance of probabilities. Furthermore, the Court found that the case at bar was not a case that permitted an inference of general causation to be drawn from the evidence of association and biological plausibility. None of the experts or the regulators were prepared to commit to an opinion that the association between AndroGel and serious CV events was causal, and the plaintiffs’ experts admitted that “association” does not establish “causation”. Applying a “but-for” test, based on the evidence, the Court was not convinced that AndroGel could cause heart attacks or other serious CV events on a balance of probabilities and concluded that there was no genuine issue requiring a trial about general causation.
Is There a Genuine Issue Requiring a Trial About the Duty to Warn?
The Court held that an association between a product and a dangerous condition may give rise to a duty to warn on the part of a manufacturer even if the association has not been demonstrated to be causal. While the Court did not make a finding about whether or not the defendants breached a duty to warn (while noting that the evidence tended to favour the view that the warnings were adequate), the Court held that the plaintiffs’ failure to warn claim must still fail, because even assuming a breach of the standard of care, they failed to prove general causation. A defendant’s failure to warn that causes no harm is not negligent. Further, the Court found that there was no genuine issue requiring a trial about the duty to warn because the plaintiffs were unable to prove that any harm was caused by the breach of that duty.
Unjust Enrichment and Pure Economic Loss
As a factual matter, the Court found that on the evidentiary record produced, physicians were diagnosing their patients as having LowT on a set of symptoms and prescribed them AndroGel as the treatment for that diagnosis. In these circumstances, the Court concluded “…almost by definition it cannot be said that a worthless good was being sold”.
As a legal matter, the Court found that the plaintiffs’ unjust enrichment claim failed because following Arora v. Whirlpool Canada LP, there is no pure economic loss for selling worthless or shoddy goods that are not dangerous for the uses for which they are sold. AndroGel was not a shoddy good and any of the dangers in its use, insofar as they were known to exist, had been disclosed in the warnings provided.
Given that general causation had not been established, the Court found that there was no predicate wrongdoing upon which to base the novel claim of waiver of tort.
The decision in Wise demonstrates that summary judgment can be an effective tool for defendants in the resolution of a class proceeding, in appropriate cases. Wise further suggests that Ontario courts are entirely embracing the “culture shift” called for in Hryniak v. Mauldin, and the move away from the conventional trial and a broad interpretation of the summary judgment rules in the interests of fairness and proportionality. In the wake of Wise, defendants will want to carefully consider seeking leave to bring a summary judgment motion before certification.